The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Indeflator Xx.
| Device ID | K896849 |
| 510k Number | K896849 |
| Device Name: | ACS INDEFLATOR XX |
| Classification | Syringe, Balloon Inflation |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula, CA 92591 |
| Contact | Kevin Corrigan |
| Correspondent | Kevin Corrigan ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula, CA 92591 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-05 |
| Decision Date | 1990-02-28 |